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Comparing 14 F Pigtail Catheter to Traditional 28-32F Chest Tube in the Management of Traumatic Hemothorax and Hemopneumothorax

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ClinicalTrials.gov Identifier: NCT02553434
Recruitment Status : Unknown
Verified September 2015 by Narong Kulvatunyou, University of Arizona.
Recruitment status was:  Not yet recruiting
First Posted : September 17, 2015
Last Update Posted : September 17, 2015
Sponsor:
Information provided by (Responsible Party):
Narong Kulvatunyou, University of Arizona

Brief Summary:
After sustaining severe trauma to the chest, patients will often bleed into the chest cavity pleural space) which is called hemothorax or they may also experience air leakage within the chest cavity in combination with the bleeding (hemopneumothorax). The treatment for these conditions include the insertion of a tube into the chest called a chest tube). Insertion of the chest tube is commonly very painful for the patient due to the size or diameter of the tube. Alternatively, procedure it is standard practice in the acute care setting at Banner-University of Arizona Tucson Campus (B-UATC) to insert a pigtail catheter, which has a smaller diameter, into the chest wall to treat the hemothorax or hemopnuemothorax. The primary purpose of this study is to see if the use of the pigtail catheter is just as effective as chest tube insertion in terms of removing leaked blood and/or air from the chest cavity. An additional objective of this study is to evaluate which procedure is less painful for the patient.

Condition or disease Intervention/treatment Phase
Traumatic Hemothorax Device: Pigtail catheter Phase 3

Detailed Description:

The standard treatment for traumatic hemothorax (HTX) and hemopneumothorax (HPTX) has been an insertion of a large-bore chest tube (CT) (French 28-32). The procedure is associated with significant patient's pain and discomfort. Investigator's institution has taken a lead role to replace chest tube insertion with pigtail catheter (PC) (14F) insertion. The investigators have previously published that, not only PC works just as well as the traditional CT for both pneumothorax 1) and hemothorax( 2), but it is also associated with a significant less insertion pain and tube site pain (3). In that hemothorax study, investigator reported 36 patients who received PC for HTX (2) with the same success as 32-36F chest tube in term of initial output and success rate; success rate was defined as no further intervention was needed. Since the completion of that study (December 2011), investigator's division has inserted probably 100 PC for hemothorax and hemopneumohthorax Therefore, the investigators now believe that it is time for the investigator to demonstrate the efficacy of the PC for hemothorax with a prospective and randomized study as the investigator had done previously for traumatic pneumothorax (3).

The investigators hypothesize that pigtail catheter will be just as effective as the chest tube in patients with traumatic HTX and HPTX.

The investigators' study aim is to demonstrate the efficacy of the pigtail catheter in a prospective and randomized fashion as we have done previously in pneumothorax.

The investigators' primary end point is the success/failure rate. Failure is defined as a second intervention is required i.e., second tube, video-assisted thoracoscopy (VATS), etc.

The investigators' secondary end points are the amount of initial tube drainage, 24-hour, 48-hour, 72-hour; and complications, hospital length of stay, and chest tube or pigtail insertion experience as expressed by the patient.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective and Randomized Study Comparing 14 F Pigtail Catheter to Traditional 32-36F Chest Tube in the Management of Traumatic Hemothorax and Hemopneumothorax
Study Start Date : September 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Pigtail catheter (case)
Inserting 14 French pigtail catheter
Device: Pigtail catheter
Insertion of pigtail catheter
Other Name: small-bore catheter

No Intervention: Chest tube
inserting 32-36 French chest tube



Primary Outcome Measures :
  1. Number of participants with failure of initial intervention [ Time Frame: 1 year ]
    Requiring a second intervention i.e., second tube, VATS, etc


Secondary Outcome Measures :
  1. initial drainage (blood) output at the time of tube insertion [ Time Frame: 1 year ]
    the amount of blood that comes out when tube is placed



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 18
  2. Traumatic hemothorax/HPTX requiring chest tube insertion (but not as an emergency)
  3. Patient is conscious, GCS 14-15, and able to report tube insertion experience
  4. English speaking subjects (we plan to have the consent translated in Spanish following approval)

Exclusion Criteria:

  1. Emergent indication, hemodynamic instability
  2. Patient refuses to participate
  3. Prisoner
  4. Intubation and/or on the ventilator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02553434


Contacts
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Contact: Narong Kulvatunyou, MD 520-626-6608 nkulvatunyou@surgery.arizona.edu

Sponsors and Collaborators
Narong Kulvatunyou
Investigators
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Principal Investigator: Narong Kulvatunyou, MD University of Arizona

Publications of Results:
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Responsible Party: Narong Kulvatunyou, Associate Professor, Surgery, University of Arizona
ClinicalTrials.gov Identifier: NCT02553434     History of Changes
Other Study ID Numbers: 1506936985
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: September 17, 2015
Last Verified: September 2015
Keywords provided by Narong Kulvatunyou, University of Arizona:
pigtail catheter
small-bore catheter
trauma
hemothorax
Additional relevant MeSH terms:
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Hemothorax
Hemopneumothorax
Pleural Diseases
Respiratory Tract Diseases
Hemorrhage
Pathologic Processes